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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00525265 |
To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.
Condition | Intervention | Phase |
---|---|---|
Cardiac Edema |
Drug: OPC-41061(Tolvaptan) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Clinical Pharmacological Study of OPC-41061 in the Treatment of Cardiac Edema (Congestive Heart Failure) |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OPC-41061
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Drug: OPC-41061(Tolvaptan)
Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days.
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2: Placebo Comparator
placebo
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Drug: Placebo
Subjects will be orally administered placebo once daily after breakfast for seven days.
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Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | OPCJ ( Katsuhisa Saito ) |
Study ID Numbers: | 156-06-004 |
Study First Received: | September 3, 2007 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00525265 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Vasopressin antagonist Cardiac Edema Diuretics |
Arginine Vasopressin Signs and Symptoms Heart Failure Heart Diseases |
Edema, Cardiac Vasopressins Edema |
Cardiovascular Diseases |